The Farm Bill and the Appropriations Act amended the Act to direct the Secretary of Agriculture to promulgate regulations by September 30, 2004, requiring retailers to notify their customers of the country of origin of covered commodities. The FY 2004 Consolidated Appropriations Act (Public Law 108-199) delayed the applicability of mandatory COOL for all covered commodities except wild and farm-raised fish and shellfish until September 30, 2006.

On October 5, 2004, AMS published an interim final rule (69 FR 59708) for the mandatory country of origin labeling program for fish and shellfish. The comment period was originally scheduled to end on January 3, 2005. However, two industry trade organizations have requested additional time for retailers to examine their systems in light of the requirements of the interim final rule in order to provide more meaningful comments. Further, the Food and Drug Administration (FDA) recently published the final rule to implement the Bioterrorism Act's recordkeeping requirements and more time is needed for the industry to compare the FDA regulation recordkeeping requirements with the recordkeeping requirements under the COOL interim final rule. Therefore, AMS has determined that there is sufficient justification for extending the comment period 30 days until February 2, 2005.

In the Federal Register dated November 26, 2004, the Rural Housing Service (RHS) published an interim final rule which had the intent of streamlining and reengineering its regulations, as well as utilizing several private sector processes and techniques in the administration of the origination, management, servicing, and preservation of its Multi-Family Housing programs. These programs include the section 515 Rural Rental Housing (RRH) loan program, the section 514/516 Farm Labor Housing loan and grant program, and the section 521 Rental Assistance (RA) program. This interim final rule combines the provisions of the Streamlining and Consolidation of the sections 514, 515, 516, and 521 Multi-Family Housing (MFH) Programs Proposed Rule published on June 2, 2003, and the Operating Assistance for Off-Farm Migrant Farmworker Projects Proposed Rule published on November 2, 2000.

Due to the complex nature of the changes in the regulation, it is in the best interest of the public to extend the period of time in which comments will be accepted. Initially, the comment period was to end on December 27, 2004. The revised ending date for the receipt of comments is now January 26, 2005.

Section 216 of the Fair and Accurate Credit Transactions Act of 2003 (FACT Act or the Act) adds a new section 628 to the Fair Credit Reporting Act (FCRA), at 15 U.S.C. 1681w, that, in general, is designed to protect a consumer against the risks associated with unauthorized access to information about the consumer contained in a consumer report, such as fraud and related crimes including identity theft. Section 216 of the Act requires each of the Agencies to adopt a regulation with respect to the entities that are subject to its enforcement authority “requiring any person that maintains or otherwise possesses consumer information, or any compilation of consumer information, derived from consumer reports for a business purpose to properly dispose of any such information or compilation.” Pub. L. 108-159, 117 Stat. 1985-86. The FACT Act mandates that the Agencies ensure that their respective regulations are consistent with the requirements issued pursuant to the Gramm-Leach-Bliley Act (GLB Act) (Pub. L. 106-102), as well as other provisions of Federal law.

On June 8, 2004, the Agencies published a proposal to amend the Interagency Guidelines Establishing Standards for Safeguarding Customer Information (Guidelines) to require financial institutions to implement controls designed to ensure the proper disposal of “consumer information” within the meaning of section 216. 1 A total of 68 comments on the proposal were submitted to the Agencies, some of which were submitted to more than one of the Agencies. Most of these comments were submitted by financial institutions and associations that represent them. A few comments were submitted by trade associations from the information destruction industry. 2

In general, commenters expressed support for the Agencies' proposal because the new requirements would allow financial institutions sufficient latitude to adopt controls that suit their particular circumstances. Commenters offered revisions to several aspects of the proposal, notably the definitions and compliance deadlines, and the Agencies have considered each of these suggestions.

The Agencies also proposed to amend their respective regulations that implement the FCRA by adding a new provision setting forth the duties of users of consumer reports regarding identity theft. The proposed provision would require a financial institution to properly dispose of consumer information in accordance with the standards set forth in the Guidelines. The Agencies also proposed to amend their respective FCRA regulations by incorporating a rule of construction, which generally provides that the duty to properly dispose of consumer information shall not be construed to require a financial institution to maintain or destroy any record pertaining to a consumer that is not imposed under any other law or alter any requirement under any other law to maintain or destroy such a record. This rule of construction closely tracks section 628(b) of the FCRA, as added by section 216 of the FACT Act. In general, commenters supported the Agencies' proposal to amend their FCRA regulations and, in particular, urged the Agencies to retain the rule of construction in the final rule.

In accordance with section 216 of the Act, the Agencies have consulted with the FTC, the National Credit Union Administration, and the Securities and Exchange Commission to ensure that, to the extent possible, the rules adopted by the respective agencies are consistent and comparable.

On February 1, 2001, the Agencies issued the Guidelines pursuant to sections 501 and 505 of the GLB Act (15 U.S.C. 6801 and 6805). 3 The Guidelines establish standards relating to the development and implementation of administrative, technical, and physical safeguards to protect the security, confidentiality, and integrity of customer information. The Guidelines apply to the financial institutions subject to the Agencies' respective jurisdictions. As mandated by section 501(b) of the GLB Act, the Guidelines require each financial institution to develop a written information security program that is designed to: (1) Ensure the security and confidentiality of customer information; (2) protect against any anticipated threats or hazards to the security or integrity of such information; and (3) protect against unauthorized access to or use of such information that could result in substantial harm or inconvenience to any customer. 4 The Guidelines direct financial institutions to assess the risks to their customer information and customer information systems and, in turn, implement appropriate security measures to control those risks. 5 For example, under the risk-assessment framework currently imposed by the Guidelines, each financial institution must evaluate whether the controls the institution has developed sufficiently protect its customer information from unauthorized access, misuse, or alteration when the institution disposes of the information. 6

To implement section 216 of the FACT Act, the Agencies are adopting amendments to the Guidelines  7 that require each financial institution to develop and maintain, as part of its information security program, appropriate controls designed to ensure that the institution properly disposes of “consumer information.” The amendments to the Guidelines generally require a financial institution to properly dispose of “consumer information” derived from a consumer report in a manner consistent with a financial institution's existing obligations under the Guidelines to properly dispose of customer information. Although the Guidelines currently address an institution's obligations to properly dispose of customer information, the amendments now state this obligation more directly and combine it with the new requirement to properly dispose of consumer information.

The Agencies have incorporated this new requirement into the Guidelines by: (1) Adding a definition of “consumer information,” including illustrations of the information covered by the new term; (2) adding an objective (in paragraph II) regarding the proper disposal of customer information and consumer information; and (3) adding a provision (in paragraph III) that requires a financial institution to implement appropriate measures to properly dispose of customer information and consumer information in accordance with each of the requirements in paragraph III.

The final rule requires each financial institution to implement the appropriate measures to properly dispose of “consumer information” by July 1, 2005. The Agencies believe that any changes to an institution's existing information security program likely will be minimal because many of the measures that an institution already uses to dispose of “customer information” can be adapted to properly dispose of “consumer information.” Nevertheless, a few of the comments noted that the proposed period for compliance would be relatively short in light of the work required to locate and track all “consumer information” in a financial institution's existing information systems. Accordingly, the Agencies have determined that financial institutions should be afforded a six-month period to adjust their systems and controls.

A discussion of each proposed amendment to the Guidelines and the addition of cross-references to the Guidelines in the Agencies' FCRA regulations follows.

The proposal defined “consumer information” to mean “any record about an individual, whether in paper, electronic, or other form, that is a consumer report or is derived from a consumer report and that is maintained or otherwise possessed by or on behalf of the [institution] for a business purpose.” “Consumer information” also was defined to mean “a compilation of such records.”

Commenters generally supported the Agencies' proposed definition of this term, but argued that the Agencies should include statements or illustrations to clarify the nature and scope of “consumer information.” Several commenters found the proposed phrase “about an individual” to be ambiguous and urged the Agencies to adopt a definition expressly stating that “consumer information” only includes information that identifies a particular individual.

Similarly, some commenters supported the Agencies' explanation in the proposal that “consumer information” does not include information derived from a consumer report that does not identify any particular consumer, such as the mean credit score derived from a group of consumer reports. These commenters suggested that the Agencies include this example (or similar examples) in the definition.

In the final rule, as in the proposed rule, the Agencies have continued to define “consumer information” to mean “any record about an individual, whether in paper, electronic, or other form, that is a consumer report or is derived from a consumer report and that is maintained or otherwise possessed by or on behalf of the [institution] for a business purpose.” In addition, the Agencies have continued to define “consumer information” to mean “a compilation of such records,” as proposed.

The Agencies have modified the term “consumer information,” however, to expressly exclude from the definition “any record that does not identify an individual.” The Agencies believe that qualifying the term “consumer information” to cover only personally identifiable information appropriately focuses on the information derived from a consumer report that, if improperly disposed, could be used to commit fraud or identity theft against a consumer. The Agencies believe that limiting “consumer information” to information that identifies a consumer is consistent with the current law relating to the scope of the term “consumer report” under the FCRA and the purposes of section 216 of the FACT Act.

Under the final rule, a financial institution must implement measures to properly dispose of “consumer information” that identifies a consumer, such as the consumer's name and the credit score derived from a consumer report. However, this requirement does not apply to aggregate information, such as the mean credit score that is derived from a group of consumer reports, or blind data, such as a series of credit scores that do not identify the subjects of the consumer reports from which those scores are derived. The Agencies have included examples of records that illustrate this aspect of the Guidelines, but have not rigidly defined the nature and scope of personally identifiable information. The Agencies note that there are a variety of types of information apart from an individual's name, account number, or address that, depending on the circumstances or when used in combination, could identify the individual.

A few commenters argued that the term “consumer information” should exclude non-sensitive information about a consumer, such as names and addresses that are publicly available. These commenters urged the Agencies to limit “consumer information” to information about an individual's specific financial characteristics, such as payment history or account numbers, or personal characteristics, such as driver's license information. In their view, only sensitive, non-public information should be subject to the requirements of the rule because unauthorized access to or misuse of that information poses the greatest threats of identity theft against consumers. The Agencies believe that there is no basis to exclude certain classes of relatively non-sensitive information from the scope of “consumer information” under section 216 of the Act.

Some commenters urged the Agencies to eliminate references to business-related transactions in the discussion of the definition of “consumer information.” These commenters argued that the FCRA defines a “consumer report” only with respect to information used to determine a consumer's eligibility for “credit or insurance to be used primarily for personal, family, or household purposes.”  8 Thus, these commenters recommended that the Agencies remove references to business transactions that, in their view, would be inconsistent with the scope of the FCRA. The Agencies note that the FCRA defines a “consumer report” as encompassing a communication by a consumer reporting agency of information about a consumer that, in general, is used as a factor in establishing the consumer's eligibility for “any other purpose authorized under section 604 [of the FCRA].”  9 Among other permissible purposes, a consumer reporting agency lawfully may furnish a consumer report to a person which it has reason to believe “otherwise has a legitimate business need for the information in connection with a business transaction that is initiated by the consumer.”  10 If used in whole or in part to establish a consumer's eligibility for a business transaction that is initiated by the consumer, such as an application for a small business loan that is initiated by a sole proprietor, then that information could be a consumer report. Accordingly, a financial institution that maintains information derived from a consumer report for a business purpose including a consumer report originally obtained in connection with a “business transaction that is initiated by the consumer,” would be subject to the requirement to properly dispose of such information, pursuant to section 216 of the FACT Act.

As discussed in the proposal, the Agencies note that the scope of information covered by the terms “consumer information” and “customer information” will sometimes overlap, but will not always coincide. The definition of “consumer information” is drawn from the term “consumer” in section 603(c) of the FCRA, which defines a “consumer” as an individual, without elaboration. 15 U.S.C. 1681a(c). By contrast, “customer information” under the Guidelines, means nonpublic personal information about a “customer,” namely, an individual who obtains a financial product or service to be used primarily for personal, family, or household purposes and who has a continuing relationship with the financial institution. 11

The relationship between “consumer information” and “customer information” can be illustrated through the following examples. Payment history information from a consumer report about an individual, who is a financial institution's customer, will be both “consumer information” because it comes from a consumer report and “customer information” because it is nonpublic personal information about a customer. In some circumstances, “customer information” will be broader than “consumer information.” For instance, information about a financial institution's own transactions with its customer is “customer information” but is not “consumer information” because it does not come from a consumer report. In other circumstances, “consumer information” will be broader than “customer information.” “Consumer information” includes information from a consumer report that an institution obtains about an individual who applies for but does not receive a loan, an individual who guarantees a loan (including a loan to a business entity), an employee or a prospective employee, or an individual in connection with a loan to the individual's sole proprietorship. In each of these instances, the consumer reports are not “customer information” because the information is not about a “customer” within the meaning of the Guidelines.

The Agencies believe that the phrase “derived from consumer reports” covers all of the information about a consumer that is taken from a consumer report, including information that results in whole or in part from manipulation of information from a consumer report or information from a consumer report that has been combined with other types of information. Consequently, a financial institution that possesses any of this information must properly dispose of it. For example, any record about a consumer derived from a consumer report, such as the consumer's name and credit score, that is shared among affiliates must be disposed of properly by each affiliate that possesses that information. 12 Similarly, a consumer report that is shared among affiliated companies after the consumer has been given a notice and has elected not to opt out of that sharing, and therefore is no longer a “consumer report” under the FCRA, 13 would still be “consumer information.” Accordingly, an affiliate that receives “consumer information” under these circumstances must properly dispose of the information.

A few commenters suggested that the Agencies modify this provision to limit the obligation of a financial institution to properly dispose of consumer information only when the institution knows that the information has been derived from a consumer report. The Agencies believe that implementing such a limitation is unwarranted in light of the general duty established in section 216 of the Act which applies to “any person that maintains or otherwise possesses consumer information,” without regard to whether the person actually knows that it possesses such information.

The Agencies note that the proposed definition of “consumer information” includes the qualification “for a business purpose,” as set forth in section 216 of the Act. The Agencies believe that the phrase “for a business purpose” encompasses any commercial purpose for which a financial institution might maintain or possess “consumer information.” Commenters did not raise concerns about this interpretation.

Some commenters urged the Agencies to define the term “disposal” to clarify whether the sale, donation, or transfer of any medium containing “consumer information” is covered by the requirements imposed under the Guidelines. A few other commenters, however, disagreed with this suggestion and supported the Agencies' proposal, which was silent with respect to this particular term. The Agencies believe that there is no need to adopt a definition of the term “disposal” because, in the context of the duty imposed under section 216 of the FACT Act, the ordinary meaning of that term applies. The Agencies note that any sale, lease, or other transfer of any medium containing “consumer information” constitutes disposal of the information insofar as the information itself is not the subject of the sale, lease, or other transfer between the parties. By contrast, the sale, lease, or other transfer of consumer information from a financial institution to another party (which may be subject to limitations imposed under other laws) can be distinguished from the act of throwing out or getting rid of consumer information, and accordingly, does not constitute “disposal” that is subject to the Agencies' rule.

The Agencies proposed to add a new objective regarding the proper disposal of consumer information in paragraph II.B. of the Guidelines. A few commenters expressed objections to this aspect of the proposal, mainly insofar as this provision relates to service providers.

Under the final rule, a financial institution must design its information security program to satisfy the general objective to “[e]nsure the proper disposal of customer information and consumer information.” The added reference to “customer information” more directly states an institution's overall duties with respect to disposing of information. However, because proper disposal of customer information already is part of a financial institution's obligation in designing and maintaining its information security program under the Guidelines, the inclusion of “customer information” in the objective does not impose a new requirement on an institution's compliance with the Guidelines.

The general objective to “[e]nsure the proper disposal of customer information and consumer information” replaces the proposed provision that would require an institution to develop controls “in a manner consistent with the disposal of customer information.” The Agencies believe that setting forth the obligation in this manner more directly states a financial institution's obligation to develop and maintain risk-based measures to dispose of both types of information properly and is consistent with the Guidelines and the Act.

The Agencies continue to believe that imposing this additional objective in paragraph II.B is important because this disposal requirement applies to a financial institution's “consumer information” maintained or otherwise in the possession of the institution's service providers. The Guidelines require, in part, that a financial institution “[r]equire its service providers by contract to implement appropriate measures designed to meet the objectives of these Guidelines.”  14

By expressly incorporating a provision in paragraph II.B., each financial institution must contractually require its service providers to develop appropriate measures for the proper disposal of consumer information and, where warranted, to monitor its service providers to confirm that they have satisfied their contractual obligations. As several commenters observed, the particular contractual arrangements that an institution may negotiate with a service provider may take varied forms or use general terms. As a result, some institutions may have existing contracts that cover the proper disposal of customer information and consumer information. The Agencies continue to believe that the parties should be allowed substantial latitude in negotiating the contractual terms appropriate to their arrangement in any manner that satisfies the objectives of the Guidelines. Accordingly, the Agencies have not prescribed any particular standards that relate to this contract requirement.

The Agencies have made a technical amendment to the definition of “service provider” in paragraph I.C.2. to include a reference to “consumer information” in addition to “customer information.” Thus the amended definition of service provider is “any person or entity that maintains, processes, or otherwise is permitted access to customer information or consumer information through its provision of services directly to the bank.” Consistent with section 216 and the amendments to the Guidelines, a financial institution's obligation with respect to a service provider that has access to consumer information is limited to ensuring that the service provider properly disposes of consumer information.

The Agencies also have amended paragraph III.G.2. to allow a financial institution a reasonable period of time, after the final regulations are issued, to amend its contracts with its service providers to incorporate the necessary requirements in connection with the proper disposal of consumer information. After reviewing the comments on this provision of the proposal, which uniformly advocated a longer period of time for modifying contracts with service providers if necessary, the Agencies have determined that financial institutions must modify any affected contracts not later than July 1, 2006.

The Agencies have amended paragraph III.C. ( Manage and Control Risk ) of the Guidelines by adding a new provision to require a financial institution to develop, implement, and maintain, as part of its information security program, appropriate measures to properly dispose of customer information and consumer information. Like the provision described in the proposal, this new provision requires an institution to implement these measures “in accordance with each of the requirements in this paragraph III.” of the Guidelines.

Paragraph III. of the Guidelines presently requires a financial institution to undertake measures to design, implement, and maintain its information security program to protect customer information and customer information systems. Because “customer information systems” is defined to include any methods used to dispose of customer information, a financial institution presently must use risk-based measures to protect customer information in the course of disposing of it. Building on this provision in the Guidelines, the Agencies proposed a provision in paragraph III.C. that would require a financial institution to develop controls “in a manner consistent with the disposal of customer information.” Commenters generally supported this provision because a financial institution would be permitted to develop and implement risk-based protections, rather than adopt particular methods for disposing of consumer information that would comply with a prescriptive standard.

Under the final rule, an institution must adopt procedures and controls to properly dispose of “consumer information” and “customer information.” Instead of describing a financial institution's obligation to dispose of “consumer information” in relation to the standard for “customer information” (which is currently set forth in discrete provisions of the Guidelines), the Agencies have determined that the obligation should be stated directly and generally. A provision that requires each financial institution to develop and maintain risk-based measures to properly dispose of customer information and consumer information more clearly states an institution's responsibilities to properly dispose of both classes of information and is consistent with the Guidelines and the Act.

Under this provision of the final rule, a financial institution must broaden the scope of its risk assessment to include an assessment of the reasonably foreseeable internal and external threats associated with the methods it uses to dispose of “consumer information,” and adjust its risk assessment in light of the relevant changes relating to such threats. By expressly adding this new provision, the Agencies are requiring a financial institution to integrate into its information security program each of those risk-based measures in connection with the disposal of “consumer information,” as set forth in paragraph III. of the Guidelines.

Some commenters urged the Agencies to adopt a detailed standard for the destruction of information or criteria that define “proper” methods or levels of disposal, rather than a provision that tracks the general obligation imposed under section 216 of the FACT Act. Other commenters favored the approach set forth in the proposal and argued that the general duty to “properly dispose of consumer information” is appropriately suited to the varying circumstances that financial institutions confront.

After reviewing the comments, the Agencies continue to believe that it is not necessary to propose a prescriptive rule describing proper methods of disposal. Nonetheless, consistent with interagency guidance previously issued through the Federal Financial Institutions Examination Council (FFIEC), 15 the Agencies expect institutions to have appropriate disposal procedures for records maintained in paper-based or electronic form. The Agencies note that an institution's information security program should ensure that paper records containing either customer or consumer information should be rendered unreadable as indicated by the institution's risk assessment, such as by shredding or any other means. Institutions also should recognize that computer-based records present unique disposal problems. Residual data frequently remains on media after erasure. Since that data can be recovered, additional disposal techniques should be applied to sensitive electronic data. 16

As set forth in the proposal, the Agencies' final rules create a cross-reference to the Guidelines in their respective regulations that implement the FCRA  17 by adding a provision setting forth the duties of users of consumer reports regarding identity theft. Commenters generally agreed with the Agencies' proposal to create the cross-reference. In particular, commenters supported the Agencies' proposal to make explicit in the regulations the rule of construction in the statute stating that the requirement pertaining to proper disposal under the FCRA shall not be construed as requiring a person to maintain or destroy a record containing consumer information and does not alter any requirement imposed under other law to maintain or destroy such a record.

The new provision requires a financial institution to properly dispose of consumer information in accordance with the standards set forth in the Guidelines. This provision applies to an institution to the extent that the institution is covered by the scope of the Guidelines. 18 The provision also incorporates a rule of construction that closely tracks the terms of section 628(b) of the FCRA, as added by section 216 of the FACT Act. 19

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) and its implementing regulations at 5 CFR part 1320, including Appendix A.1, the Agencies have reviewed the final rules and determined that they contain no collections of information. The Board made this determination under authority delegated by the Office of Management and Budget.

In accordance with the Regulatory Flexibility Act, each agency must publish a final regulatory flexibility analysis with its final rule, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. (5 U.S.C. 601-612). Each of the Agencies hereby certifies that its final rule does not have a significant economic impact on a substantial number of small entities.

The rules require a financial institution subject to the jurisdiction of the appropriate agency to implement appropriate controls designed to ensure the proper disposal of “consumer information.” A financial institution must develop and maintain these controls as part of implementing its existing information security program for “customer information,” as required under the Guidelines. 20

Any modifications to a financial institution's information security program needed to address the proper disposal of “consumer information” could be incorporated through the process the institution presently uses to adjust its program under paragraph III.E. of the Guidelines, particularly because of the similarities between customer information and consumer information and the measures commonly used to properly dispose of both types of information. To the extent that these rules impose new requirements for certain types of “consumer information,” developing appropriate measures to properly dispose of that information likely would require only a minor modification of an institution's existing information security program.

Because some “consumer information” will be “customer information” and because segregating particular records for special treatment may entail considerable costs, the Agencies believe that many banks and savings associations, including small institutions, already are likely to have implemented measures to properly dispose of both “customer” and “consumer” information. In addition, the Agencies, through the Federal Financial Institutions Examination Council (FFIEC), already have issued guidance regarding their expectations concerning the proper disposal of all of an institution's paper and electronic records. See FFIEC Information Technology Examination Handbook, Information Security Booklet, December 2002, p. 63. 21 Therefore, the rules do not require any significant changes for institutions that currently have procedures and systems designed to comply with this guidance.

The Agencies anticipate that, in light of current practices relating to the disposal of information in accordance with the Guidelines and the guidance issued by the FFIEC, the final rules will not impose undue costs on financial institutions. Therefore, the Agencies believe that the controls that small financial institutions will develop and implement, if any, to comply with the rules likely pose a minimal economic impact on those entities.

The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Pub. L. 104-121, 110 Stat. 857) provides generally for agencies to report rules to Congress and for Congress to review these rules. The reporting requirement is triggered in instances where the FDIC issues a final rule as defined by the Administrative Procedure Act (APA) (5 U.S.C. 551, et seq. ). Because the FDIC is issuing a final rule as defined by the APA, the FDIC will file the reports required by SBREFA.

The OCC and OTS each have determined that this rule is not a “significant regulatory action” under Executive Order 12866.

Under Section 202 of the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4 (2 U.S.C. 1532) (Unfunded Mandates Act), the OCC and OTS must prepare budgetary impact statements before promulgating any rule likely to result in a federal mandate that may result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year. If a budgetary impact statement is required, under section 205 of the Unfunded Mandates Act, the OCC and OTS must identify and consider a reasonable number of regulatory alternatives before promulgating a rule.

For the reasons outlined earlier, the OCC and OTS have determined that this proposal will not result in expenditures by state, local, and tribal governments, or by the private sector, of $100 million or more, in any one year. Accordingly, a budgetary impact statement is not required under section 202 of the Unfunded Mandates Reform Act of 1995 and this rulemaking requires no further analysis under the Unfunded Mandates Act.

The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq. ) as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 (Public Law 101-629), the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115), and the Medical Device User Fee and Modernization Act of 2002 (Public Law 107-250), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513 of the act, FDA refers to devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), as “preamendments devices.” FDA classifies these devices after the agency takes the following steps: (1) Receives a recommendation from a device classification panel (an FDA advisory committee); (2) publishes the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) publishes a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

FDA refers to devices that were not in commercial distribution before May 28, 1976, as “postamendments devices.” These devices are classified automatically by statute (section 513(f) of the act into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until FDA initiates the following procedures: (1) FDA reclassifies the device into class I or II; (2) FDA issues an order classifying the device into class I or II in accordance with new section 513(f)(2) of the act, as amended by FDAMA; or (3) FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the act, to a predicate device that does not require premarket approval.

The agency determines whether new devices are substantially equivalent to predicate devices by means of the premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).

Consistent with the act and the regulations, FDA consulted with the Gastroenterology and Urology Devices Panel (the panel), an FDA advisory committee, regarding the classification of this device.

FDAMA added a new section 510(m) to the act (21 U.S.C. 360(m)). New section 510(m) of the act provides that a class II device may be exempted from the premarket notification requirements under section 510(k) of the act, if the agency determines that premarket notification is not necessary to assure the safety and effectiveness of the device. FDA has determined that premarket notification is not necessary to assure the safety and effectiveness of external penile rigidity devices.

FDA believes that for devices of a type generally exempt from premarket notification, certain modifications to these devices may change the intended use of these devices to an intended use that is of substantial importance in preventing impairment of human health, or may cause these devices to present unreasonable risks of illness or injury. Accordingly, devices changed in this manner would require premarket notification. For example, FDA considers a class II device to be subject to premarket notification requirements if the device operates using a different fundamental scientific technology than that used by a legally marketed device in that generic type.

In the Federal Register of March 17, 2004 (69 FR 12598), FDA proposed to classify external penile rigidity devices intended to create or maintain sufficient penile rigidity for sexual intercourse into class II (special controls). FDA also proposed to exempt the devices from premarket notification requirements. Also in the Federal Register of March 17, 2004 (69 FR 26398), FDA announced the availability of a draft guidance document that FDA intended to serve as the special control for external penile rigidity devices. FDA invited interested persons to comment on the draft guidance document and invited comment on the proposed regulation by June 15, 2004. FDA received no comments on the proposed rule or draft guidance.

In accordance with 21 CFR 860.84(g)(2), FDA is classifying external penile rigidity devices into class II (special controls). FDA is codifying the classification of external penile rigidity devices by adding § 876.5020. The agency is also exempting these devices from premarket notification requirements. The guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices” will serve as the special control for external penile rigidity devices. Following the effective date of the final classification rule, manufacturers will need to address the issues covered in this special control guidance. However, the manufacturer need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. For the convenience of the reader, in part 876 (21 CFR part 876) FDA is also adding § 876.1(e) to inform the reader where to find guidance documents referenced in that part.

FDA received no comments on the proposed rule. Therefore, under section 513 of the act, FDA is adopting the summary of reasons for the panel's recommendation and the summary of data upon which the panel's recommendation is based. FDA is also adopting the assessment of the risks to public health stated in the proposed rule published on March 17, 2004. FDA is issuing this final rule which classifies the generic type of device, external penile rigidity devices, into class II (special controls). In addition, FDA, on its own initiative, is exempting external penile rigidity devices from premarket notification requirements.

The agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety and other advantages, distributive impacts, and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. This final rule will relieve a burden and simplify marketing by exempting the devices from premarket notification requirements. The guidance document is based on existing review practices and will not impose new burdens on manufacturers of these devices. The agency, therefore, certifies that this final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any 1 year. The current threshold after adjustment for inflation is $110 million. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

FDA has analyzed the final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies conferring substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order. As a result, a federalism summary impact statement is not required.

FDA concludes that this rule contains no collection of information that is subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995.

The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. These references may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

1. The authority citation for 21 CFR part 876 continues to read as follows:

2. Section 876.1 is amended by adding paragraph (e) to read as follows:

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976 (the amendments), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations.

Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a document in the Federal Register announcing such classification (section 513(f)(2) of the act).

In accordance with section 513(f)(1) of the act, FDA issued a document on August 10, 2004, classifying the Hamilton Thorne Zona Infrared Laser Optical System (ZILOS-tkr) into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On August 25, 2004, Hamilton Thorne Biosciences, Inc., submitted a petition requesting classification of this device under section 513(f)(2) of the act. The manufacturer recommended that the device be classified into class II (Ref. 1).

In accordance with section 513(f)(2) of the act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in 513(a)(1) of the act. Devices are to be classified into class II if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA has determined that the device can be classified in class II with the establishment of special controls. FDA believes that class II special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

The device is assigned the generic name assisted reproduction laser system and it is identified as a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.

The potential risks to health associated with the device are: (1) Damage to the embryo, (2) ineffective treatment, (3) hazards associated with electrical equipment, and (4) electromagnetic interference and electrostatic discharge hazards. The special controls guidance document entitled “Class II Special Controls Document: Assisted Reproduction Laser Systems” aids in mitigating the risks by recommending performance characteristics, safety testing, and appropriate labeling.

Thus, in addition to the general controls of the act, an assisted reproduction laser system, is subject to the special controls guidance document. FDA believes that following the class II special controls guidance document generally addresses the risks to health identified in the previous paragraph. On November 4, 2004, FDA issued an order to the petitioner classifying the device as described previously into class II and is codifying this classification by adding 21 CFR 884.6200.

Following the effective date of this final classification rule, any firm submitting a 510(k) (premarket notification) will need to address the issues covered in the special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness; therefore, the device is not exempt from premarket notification requirements. Thus, persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the device they intend to market.

The agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because classification of this device type into class II will relieve manufacturers of the device of the cost of complying with the premarket approval requirements of section 515 of the act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the agency certifies that the final rule will not have a significant impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $110 million. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

The collection of information contained in these final regulations has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act (44 U.S.C. 3507) under control number 1545-1765. Responses to this collection of information are mandatory so that a taxpayer may claim a new markets tax credit on each credit allowance date during the 7-year credit period and report compliance with the requirements of section 45D to the Secretary.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number assigned by the Office of Management and Budget.

The estimated annual burden per respondent varies from 15 minutes to 5 hours, depending on individual circumstances, with an estimated average of 2.5 hours.

Comments concerning the accuracy of this burden estimate and suggestions for reducing this burden should be sent to the Internal Revenue Service, Attn: IRS Reports Clearance Officer, SE:W:CAR:MP:T:T:SP Washington, DC 20224, and to the Office of Management and Budget, Attn: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503.

Books or records relating to this collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

This document amends 26 CFR part 1 to provide rules relating to the new markets tax credit under section 45D of the Internal Revenue Code (Code). On December 26, 2001, the IRS published in the Federal Register temporary and proposed regulations (the 2001 temporary regulations) (66 FR 66307, 66 FR 66376). On March 11, 2004, the IRS published in the Federal Register temporary and proposed regulations revising and clarifying the 2001 temporary regulations (the 2004 temporary regulations) (69 FR 11507; 69 FR 11561). On March 14, 2002, and June 2, 2004, the IRS and Treasury Department held public hearings on the 2001 temporary regulations and the 2004 temporary regulations, respectively. Written and electronic comments responding to the temporary regulations and notices of proposed rulemaking were received. After consideration of all the comments, the proposed regulations are adopted as amended by this Treasury decision, and the corresponding temporary regulations are removed. The revisions are discussed below.

Section 45D was added to the Code by section 121(a) of the Community Renewal Tax Relief Act of 2000 (Pub. L. 106-554). The Secretary has delegated certain administrative, application, allocation, monitoring, and other programmatic functions relating to the new markets tax credit program to the Under Secretary (Domestic Finance), who in turn has delegated those functions to the Community Development Financial Institutions Fund.

Sections 221 and 223 of the American Jobs Creation Act of 2004 (Pub. L. 108-357) amended the definition of a low-income community under section 45D(e). This document does not provide guidance on these amendments. The IRS and Treasury Department are studying the amendments for guidance in the near future.

Taxpayers may claim a new markets tax credit on a credit allowance date in an amount equal to the applicable percentage of the taxpayer's qualified equity investment in a qualified community development entity (CDE). The credit allowance date for any qualified equity investment is the date on which the investment is initially made and each of the 6 anniversary dates thereafter. The applicable percentage is 5 percent for the first 3 credit allowance dates and 6 percent for the remaining credit allowance dates.

A CDE is any domestic corporation or partnership if: (1) The primary mission of the entity is serving or providing investment capital for low-income communities or low-income persons; (2) the entity maintains accountability to residents of low-income communities through their representation on any governing board of the entity or on any advisory board to the entity; and (3) the entity is certified by the Secretary for purposes of section 45D as being a CDE.

The new markets tax credit may be claimed only for a qualified equity investment in a CDE. A qualified equity investment is any equity investment in a CDE for which the CDE has received an allocation from the Secretary if, among other things, the CDE uses substantially all of the cash from the investment to make qualified low-income community investments. Under a safe harbor, the substantially-all requirement is treated as met if at least 85 percent of the aggregate gross assets of the CDE are invested in qualified low-income community investments.

Qualified low-income community investments consist of: (1) Any capital or equity investment in, or loan to, any qualified active low-income community business; (2) the purchase from another CDE of any loan made by such entity that is a qualified low-income community investment; (3) financial counseling and other services to businesses located in, and residents of, low-income communities; and (4) certain equity investments in, or loans to, a CDE.

In general, a qualified active low-income community business is a corporation or a partnership if for the taxable year: (1) At least 50 percent of the total gross income of the entity is derived from the active conduct of a qualified business within any low-income community; (2) a substantial portion of the use of the tangible property of the entity is within any low-income community; (3) a substantial portion of the services performed for the entity by its employees is performed in any low-income community; (4) less than 5 percent of the average of the aggregate unadjusted bases of the property of the entity is attributable to certain collectibles; and (5) less than 5 percent of the average of the aggregate unadjusted bases of the property of the entity is attributable to certain nonqualified financial property.

A recapture event requiring an investor to recapture credits previously taken occurs for an equity investment in a CDE if the CDE: (1) Ceases to be a CDE; (2) ceases to use substantially all of the proceeds of the equity investment for qualified low-income community investments; or (3) redeems the investor's equity investment. In addition, the investor's basis in any qualified equity investment is reduced by the amount of the new markets tax credit.

As indicated above, a CDE must use substantially all of the cash from a qualified equity investment to make qualified low-income community investments. Section 1.45D-1T(c)(5)(i) provides that the substantially-all requirement is treated as satisfied for an annual period if either the direct-tracing calculation under § 1.45D-1T(c)(5)(ii), or the safe harbor calculation under § 1.45D-1T(c)(5)(iii), is performed every six months and the average of the two calculations for the annual period is at least 85 percent. The final regulations clarify that a CDE may choose the same two testing dates for all qualified equity investments regardless of the date each qualified equity investment was initially made. To conform the annual testing requirement with the 12-month time limit for making qualified low-income community investments, the final regulations provide that for the first annual period, the substantially-all calculation may be performed on a single testing date. The final regulations also amend the beginning of the 12-month period for making qualified low-income community investments to provide that the 12-month period begins on the same date as the beginning of the first annual period of the 7-year credit period.

Section 1.45D-1T(d)(3) provides that reserves (not in excess of 5 percent of the taxpayer's cash investment under § 1.45D-1T(b)(4)) maintained by the CDE for loan losses or for additional investments in existing qualified low-income community investments are treated as invested in a qualified low-income community investment. In response to comments, the final regulations provide that reserves include fees paid to third parties to protect against loss of all or a portion of the principal of, or interest on, on a loan that is a qualified low-income community investment.

As indicated above, qualified low-income community investments include any capital or equity investment in, or loan to, any qualified active low-income community business. Under § 1.45D-1T(d)(4)(i)(B), an entity is a qualified active low-income community business only if, among other requirements, at least 40 percent of the use of the tangible property of such entity (whether owned or leased) is within any low-income community. In response to comments, the final regulations provide an example of how the tangible property test applies to property that is used both outside and inside a low-income community. The example demonstrates that use is measured based on the entity's business hours of operation and does not include non-business hours.

Under section 45D(d)(2)(C), a qualified active low-income community business includes any trade or business that would qualify as a qualified active low-income community business if such trade or business were separately incorporated. Commentators requested clarification of how this rules applies.

The final regulations provide that a CDE may treat any trade or business (or portion thereof) as a qualified active low-income community business if the trade or business (or portion thereof) would meet the requirements to be a qualified active low-income community business if the trade or business (or portion thereof) were separately incorporated and a complete and separate set of books and records is maintained for that trade or business (or portion thereof). The final regulations further provide, however, that under this rule a CDE's capital or equity investment or loan is not a qualified low-income community investment to the extent the proceeds of the investment or loan are not used for the trade or business (or portion thereof) that is treated as a qualified active low-income community business.

Section § 1.45D-1T(d)(4)(iv) provides that an entity will be treated as engaged in the active conduct of a trade or business if, at the time the CDE makes a capital or equity investment in, or loan to, the entity, the CDE reasonably expects that the entity will generate revenues (or, in the case of a nonprofit corporation, receive donations) within 3 years after the date the investment or loan is made. The final regulations amend this rule with respect to a nonprofit corporation by providing that the nonprofit corporation must be engaged in an activity that furthers its purpose as a nonprofit corporation within the 3-year period.

Under § 1.45D-1T(d)(4)(i)(E), an entity is a qualified active low-income community business only if, among other requirements, less than 5 percent of the average of the aggregate unadjusted bases of the property of such entity is attributable to nonqualified financial property (as defined in section 1397C(e)). Section 1397C(e)(1) contains an exception to the definition of nonqualified financial property for reasonable amounts of working capital held in cash, cash equivalents, or debt instruments with a term of 18 months or less. The final regulations provide that, for these purposes, the proceeds of a capital or equity investment or loan by a CDE that will be expended on construction of real property within 12 months after the date the investment or loan is made qualify as a reasonable amount of working capital.

Section 45D(d)(3)(A) provides that the rental to others of real property located in any low-income community is treated as a qualified business only if, among other requirements, there are substantial improvements located on such property. Commentators requested clarification of the term substantial improvements . The final regulations provide that the term substantial improvements means improvements the cost basis of which equals or exceeds 50 percent of the cost basis of the land on which the improvements are located and the costs of which are incurred after the date the CDE makes the investment or loan. In addition, the final regulations provide that a CDE's investment in or loan to a business engaged in the rental of real property is not a qualified low-income community investment to the extent any lessee of the real property is not a qualified business.

As indicated above, there is a recapture event with respect to an equity investment in a CDE if such investment is redeemed by the CDE. Commentators requested clarification of when distributions by a CDE to its investors will be treated as redemptions. The final regulations provide guidance on when a distribution by a CDE that is a corporation for Federal tax purposes will be treated as a redemption.

Some commentators suggested that, in the case of a CDE that is treated as a partnership for Federal tax purposes, a redemption should be limited to purchases by the CDE of a partner's capital interest. Alternatively, commentators requested guidance on how to distinguish between a return of capital and a distribution of profits if a return of capital is treated as a redemption. In response to comments, the final regulations provide a safe harbor under which cash distributions by a partnership will not be treated as a redemption. Under the safe harbor, a pro rata cash distribution by the CDE to its partners based on each partner's capital interest in the CDE during the taxable year will not be treated as a redemption if the distribution does not exceed the CDE's operating income (as defined in the final regulations) for the taxable year. In addition, a non-pro rata de minimis cash distribution by a CDE to a partner or partners during the taxable year will be not treated as a redemption. A non-pro rata de minimis cash distribution may not exceed the lesser of 5 percent of the CDE's operating income for that taxable year or 10 percent of the partner's capital interest in the CDE.

Commentators suggested that cure periods be provided to enable CDEs to correct any noncompliance with the requirements under section 45D. One commentator suggested that a cure period be provided to allow an investment that no longer qualifies as a qualified low-income community investment to be replaced with a qualifying investment by the end of the calendar year following the year the original investment lost its status as a qualified low-income community investment. Other commentators suggested that, if a qualified equity investment fails the substantially-all requirement, the failure should not be a recapture event if the CDE corrects the failure within 6 months after the date the CDE discovers (or reasonably should have discovered) the failure. The final regulations provide that, if a qualified equity investment fails the substantially-all requirement, the failure is not a recapture event if the CDE corrects the failure within 6 months after the date the CDE becomes aware (or reasonably should have become aware) of the failure. Only one correction is permitted for each qualified equity investment during the 7-year credit period.

Section 45D(i)(1) authorizes the Secretary to prescribe regulations as may be appropriate to carry out section 45D including regulations that limit the new markets tax credit for investments that are directly or indirectly subsidized by other Federal tax benefits (including the low-income housing credit under section 42 and the exclusion from gross income under section 103). The final regulations do not prohibit a CDE from purchasing tax-exempt bonds because tax-exempt financing provides a subsidy to borrowers and not bondholders. However, the final regulations provide that if a CDE makes a capital or equity investment or loan with respect to a qualified low-income building under section 42, the investment or loan is not a qualified low-income community investment to the extent the building's eligible basis under section 42(d) is financed by the proceeds of the investment or loan.

The final regulations are effective December 22, 2004, and may be applied by taxpayers before December 22, 2004. However, both the definition of the term substantial improvements and the requirement that each lessee be a qualified business apply to qualified low-income community investments made on or after February 22, 2005.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. It is hereby certified that the collection of information in these regulations will not have a significant economic impact on a substantial number of small entities. This certification is based upon the fact that any burden on taxpayers is minimal. Accordingly, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Code, the notices of proposed rulemaking preceding these regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.

The principal author of these regulations is Paul F. Handleman, Office of the Associate Chief Counsel (Passthroughs and Special Industries), IRS. However, other personnel from the IRS and Treasury Department participated in their development.

On July 13, 2004, the Copyright Office published a notice of proposed rulemaking seeking comment on its proposed revision of parts 202, 211 and 212 of subchapter A of Chapter II, 37 CFR. The purpose of this notice is to announce the final rule.

This regulation establishes procedures for applicants to request that the Copyright Office reconsider refusals to register copyright claims and claims in mask works or vessel hull designs. There are two opportunities for reconsideration of a refusal to register. At the first level of reconsideration, the Examining Division of the Copyright Office reviews its initial decision to refuse registration. At the second level, the Review Board conducts the review of a refusal to register. For administrative reasons, the Copyright Office is making one change in the membership of the Review Board which considers the second request for reconsideration. The Review Board is composed of three members; the first two members are the Register of Copyrights and the General Counsel or their respective designees. The third member will be designated by the Register. This rule also establishes procedures for mailing or hand delivering requests for reconsideration and related documents.

In response to the publication of the proposed rule, the Copyright Office did not receive any comments. Consequently, the Copyright Office is adopting the previously proposed text, as a final rule, with the one administrative change noted above and without substantive change, as follows:

This action is directed to the public in general and to anyone who may want to file documents with the EAB. If you have questions regarding the applicability of this action to a particular entity or action, consult the person listed under FOR FURTHER INFORMATION CONTACT .

The Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties and the Revocation/Termination or Suspension of Permits (CROP), 40 CFR part 22, govern the filing of certain appeals with the EAB, and provide, in pertinent part, that:

The CROP further provides, in pertinent part, that:

You may obtain additional information about this action on the EAB's Internet home page at http://www.epa.gov/eab .

EPA is issuing this document under its general rulemaking authority. Reorganization Plan No. 3 of 1970 (5 U.S.C. app.). In addition, section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that this amendment is technical and non-substantive, and therefore, that there is good cause under 5 U.S.C. 553(b)(B) for making this rule final without prior proposal and opportunity for comment. EPA also finds good cause under 5 U.S.C. 553(d) to make this rule effective on the date of publication.

No. This final rule implements a technical amendment to 40 CFR part 22 to provide clear guidance on the hand-delivery address for filings with the EAB, and does not otherwise impose or amend any requirements. This action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This rule does not contain any information collection requirements that require review and approval by OMB pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Because this action is not economically significant as defined by section 3(f) of Executive Order 12866, this action is not subject to Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). Since the Agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the APA or any other statute, this action is not subject to provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), or to sections 202 and 205 of the Unfunded Mandate Reform Act of 1995 (UMRA) (Public Law 104-94). In addition, this action does not impose any enforceable duty, contain any unfunded mandate, or impose any significant or unique impact on small governments as described in the UMRA of 1995. This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Similarly, this rule will not have substantial direct effects on tribal governments, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). This action does not involve any technical standards that require the Agency's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). This rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not a significant regulatory action under Executive Order 12866.

Yes. The Congressional Review Act (CRA), 5 U.S.C. 801 et seq. , generally provides that, before a rule may take effect, the agency that promulgates the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. CRA section 808 provides that the issuing agency may make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure are impracticable, unnecessary, or contrary to the public interest. EPA has made such a good cause finding, including the reasons therefor, and has established the date of publication as the effective date. As stated previously, EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States, prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Throughout this document, “we,” “us,” and “our” refer to EPA. This supplementary information is organized as follows.

EPA is approving a SIP revision that revises the District of Columbia's ozone SIP. The SIP revision requires major stationary sources of VOC and NO X in the District of Columbia, which is part of the Metropolitan Washington DC Severe Ozone Nonattainment Area (Area), to pay a fee to the District if the Area fails to attain the national ambient air quality standard (NAAQS) for ozone by November 15, 2005. The fee must be paid beginning in 2006 and in each calendar year thereafter, until the Area is redesignated to attainment for the pollutant ozone. We are approving this rule because it is consistent with the requirements of the Clean Air Act (Act).

EPA is publishing this rule without prior proposal because we view this as a noncontroversial amendment and we anticipate no adverse comment, since no comments were received during the District's regulatory process. However, in the “Proposed Rules” section of today's Federal Register , we are publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on February 28, 2005, without further notice unless EPA receives adverse comment by January 27, 2005. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

This rule applies to major stationary VOC and NO X sources located in the District of Columbia. The District of Columbia's definition of a “major stationary source” is found at 20 DCMR section 199.1. In a separate action, EPA is approving this definition as part of the District of Columbia's ozone SIP. Pertaining to the application of this excess emissions fee for entities in the District of Columbia, a major stationary source is defined as “any stationary source of air pollutants that emits, or has the potential to emit, twenty five (25) tons per year or more of oxide of nitrogen or volatile organic compounds * * *” These sources are subject to this emissions fee rule.

The fee is initially set at $5,000 per ton of VOC or NO X emitted by the source during the previous calendar year in excess of 80% of the baseline amount. The fee is to be adjusted annually, beginning in 1991, by the percentage by which the consumer price index has been adjusted. The baseline is the lower of the source's actual or allowable VOC or NO X emissions during calendar year 2005.

Under sections 182(d)(3), (e), and 185 of the Clean Air Act (the Act), states are required to adopt an excess emissions fee regulation for ozone nonattainment areas classified as severe or extreme. This regulation requires major stationary sources of VOC in the nonattainment area to pay a fee to the state if the area fails to attain the standard by the attainment date set forth in the Act. The District of Columbia is classified as severe nonattainment area for ozone. Section 182(f) of the Act requires states to apply the same requirements to major stationary sources of oxides of nitrogen (NO X ) as are applied to major stationary sources of VOC.

As per section 185 of the Clean Air Act, the District of Columbia's regulation provides for an exception of the fee during any year that is treated as an extension year under section 181(a)(5) of the Clean Air Act.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 28, 2005. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.

This approval of the District of Columbia's Severe Ozone Nonattainment Area Fee SIP revision, as required under section 185 and 182(f) of the Clean Air Act, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

On April 16, 2004, the District of Columbia (the District) submitted several revisions to its SIP. The SIP revisions include both new regulations and amendments to Title 20 of the District of Columbia Municipal Regulations (20 DCMR). The new regulations in Title 20 DCMR (Environment), Subtitle A: Air Quality, Chapter 7, Volatile Organic Compounds are:

(1) New Section 718—“Mobile Equipment Repair and Refinishing”.

(2) New Sections 719 through 734—“Consumer Products”.

(3) New Sections 735 through 741—“Portable Fuel Containers and Spouts”.

(4) New Sections 742 through 748—“Solvent Cleaning”.

(5) New Sections 749 through 754—“Architectural and Industrial Maintenance Coating”.

The April 16, 2004 submittal also includes new definitions that were added in section 799, a new section 307 to Chapter 3—to provide for a fee penalty pursuant to section 185 of the Act, and amendments to Chapters 1, 2, 6, 7, and 8 to satisfy the Act's requirements for severe ozone nonattainment areas pursuant to the Metropolitan Washington DC 1-hour ozone nonattainment area's reclassification on January 24, 2003 from serious to severe nonattainment.

On September 20, 2004, the District supplemented its April 16, 2004 submittal. This supplemental submittal provides copies of standards that are incorporated by reference in the District's new and amended regulations and a copy of the District's responses to comments it received during its rule adoption process. On November 26, 2004, the District submitted another supplemental revision to its April 16, 2004 submittal. This supplemental submittal consists of revised versions of the new VOC regulations. These are minor revisions to the regulations which clarify the standards that are incorporated by reference and correct cross-referencing and typographical errors. This action concerns only sections 719 through 734 (Consumer Products) and revised section 799 containing the associated definitions for the District's consumer products rule. The remaining SIP revisions submitted on April 16, 2004 and supplemented on September 20, 2004 and November 26, 2004 are the subjects of separate rulemaking actions.

As stated previously, this approval pertains only to the District's regulations for consumer products. The standards and requirements contained in the District's consumer products rule are based on the Ozone Transport Commission (OTC) model rule. The OTC developed control measures into model rules for a number of source categories. The OTC consumer products model rule is based on the existing rules developed by the California Air Resources Board, which were analyzed and modified by the OTC workgroup to address VOC reduction needs in the Ozone Transport Region (OTR).

The District's consumer products rule (sections 719 through 734) applies to any person who sells, supplies, offers for sale, or manufactures consumer products on or after January 1, 2005 for use in the District. The rule sets specific VOC content limits in percent VOCs by weight for consumer products with a compliance date of January 1, 2005. Exemptions from the VOC content limits are listed in the rule. The rule also contains requirements for the following consumer products: (1) Products requiring dilution, (2) ozone depleting compounds, (3) aerosol adhesives, (4) antiperspirants or deodorants, (5) charcoal lighter materials, and (6) floor wax strippers. Alternative control plans (ACP) are also provided by allowing responsible parties the option to voluntarily enter into separate ACP agreements for the consumer products mentioned above. Criteria for innovative products exemption and requirements for variance requests are listed in the rule. In addition, the rule contains administrative requirements for labeling and reporting as well as test methods for demonstrating compliance. The test methods used to test coatings must be the most current approved method at the time testing is performed.

EPA is approving revisions to the District of Columbia SIP to establish a regulation for the control of VOC emissions from consumer products. The implementation of this rule will result in the reduction of VOC emissions from consumer products in the District of Columbia. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on February 28, 2005 without further notice unless EPA receives adverse comment by January 27, 2005. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 28, 2005. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action pertaining to the District of Columbia's consumer products rule may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

The District of Columbia submitted SIP revisions on April 16, 2004 pertaining to changes necessary to meet the more stringent requirements of section 182(d) of the CAA and to make certain clarifications. This action pertains to changes made to previously SIP-approved Sections 600.1 and 805.5 of Title 20 of the DCMRs to clarify that the allowable emission rates for particulates and NO X are expressed in pounds of pollutant per million BTUs (lbs/MMBTUs).

The April 16, 2004 SIP submittal requested approval of revisions to portions of the regulations in the 20 DCMR Chapters 6 and 8. The federally approved SIP version of these DCMRs correctly prescribes allowable particulate and NO X emission rates in pounds of pollutant per million BTUs of heat input. However, some confusion has arisen from how these allowable emission rates actually appear in the current SIP version of the regulations. For example, one such limit for particulate emissions is expressed as follows: thirteen hundredths (0.13) pounds per million BTU of heat input. While not incorrect, this has led to the allowable emission rate being abbreviated and then interpreted as 0.13 ppm, which is parts per million, rather than as 0.13lbs/MMBTUs. The revised language clarifies all of the allowable emission rates for particulates and NO X , respectively, in 20 DCMR Sections 600.1 and 805.5 to avoid this confusion. For example, the clarified version of the previously referenced particulate emission limit now reads as follows: thirteen hundredths pounds (0.13 lb) per million BTU of heat input. By expressing the allowable emission limits in this fashion, they will properly be abbreviated and correctly interpreted in lbs/MMBTUs. These revisions to clarify 20 DCMR Chapters 6 and 8 do not affect the stringency of these previously SIP-approved regulations.

EPA is approving revisions to Sections 600.1 and 805.5 of 20 DCMR to clarify how the allowable emission rates for particulates and NO X are expressed. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on February 28, 2005 without further notice unless EPA receives adverse comment by January 27, 2005. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 28, 2005. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action to approve minor clarifications to the allowable emissions rates for particulates and NO X such that they are clearly expressed in pounds of pollutant per million BTUs (lbs/MMBTUs) may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

On January 24, 2003 ( 68 FR 3410), EPA issued a final rule which reclassified the Metropolitan Washington DC 1-hour ozone nonattainment area (the Washington DC area) from serious to severe. This is commonly referred to as “bumping up” a 1-hour ozone nonattainment area. Pursuant to EPA's January 24, 2003 reclassification of the Washington DC area to severe, the District was required to adopt and submit SIP revisions to satisfy the more stringent CAA section 182(d) requirements for severe 1-hour ozone nonattainment areas. On April 16, 2004, the District submitted several SIP revisions to satisfy those mandatory severe area requirements. Among those revisions are amendments to the size thresholds for defining major stationary sources of ozone precursors and amendments to the offset ratio requirements for NSR permitting purposes. These revisions are the subject of this rulemaking action. The other revisions submitted on April 16, 2004 are the addressed in separate rulemakings.

On April 16, 2004 (and supplemented on September 20, 2004), the District submitted SIP revisions to regulations found in Chapters 1, 2, 7 and 8 of Title 20 of the District of Columbia Municipal Regulations (DCMRs). Specifically, the regulations have been revised to meet the more stringent major source definitions and offset ratio requirements for severe ozone nonattainment areas found in CAA 182(d).

Revisions have been made to 20 DCMR Chapter 2, subsection 204.4 which change the NSR offset ratio from 1.2:1 to the more stringent ratio of 1.3:1 required for the NSR permitting of major sources and major modifications of ozone precursors in the District, namely volatile organic compounds (VOCs) and nitrogen oxides (NOX).

Revisions have also been made which change the size thresholds for defining major sources of VOC and NOX to comply with the 25 ton per year size threshold requirements of the CAA for severe 1-hour ozone nonattainment areas. Specifically, 20 DCMR Chapter 1, Subsection 199.1, for permitting requirements, now defines major stationary sources of VOC and NOX as those which emit or have the potential to emit 25 tons per year or more. Title 20 DCMR Chapter 7, Subsections 715.2, 715.3 and 715.4(b), for purposes of requiring reasonably available control technology (RACT), now define major sources of VOC as those which emit, have ever emitted, have the potential to emit, or exceed in the future, emissions greater than or equal to 25 tons per year. Similarly, 20 DCMR Chapter 8, Subsections 805.1 and 805.6 and 805.7; now define major sources of NOX as those which emit or have the potential to emit 25 tons per year or more for applicability of NOX RACT requirements. Additional changes were made to include a January 1, 2005 compliance date for RACT for those sources which emit or have the potential to emit between 25 tons per year (the new threshold for defining a subject major source) and the previous major source applicability level of 50 tons per year.

These changes to the District SIP are necessary to meet the mandatory requirements for severe 1-hour ozone nonattainment areas under section 182(d) of the CAA and strengthen the current SIP.

EPA is approving revisions to regulations found in 20 DCMR Chapters 1, 2, 7 and 8 submitted by the District to satisfy the more stringent major source definitions and offset ratio requirements for severe ozone nonattainment areas found in CAA 182(d). EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on February 28, 2005 without further notice unless EPA receives adverse comment by January 27, 2005. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 28, 2005. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action to approve revisions to the District of Columbia's regulations pertaining to major source size thresholds and offset ratios to satisfy the requirements for severe 1-hour ozone nonattainment requirements may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Since the communities on the attached list have recently entered the NFIP, subsidized flood insurance is now available for property in the community.

In addition, the Federal Emergency Management Agency has identified the special flood hazard areas in some of these communities by publishing a Flood Hazard Boundary Map (FHBM) or Flood Insurance Rate Map (FIRM). The date of the flood map, if one has been published, is indicated in the fourth column of the table. In the communities listed where a flood map has been published, Section 202 of the Flood Disaster Protection Act of 1973, as amended, 42 U.S.C. 4016(a), requires the purchase of flood insurance as a condition of Federal or federally related financial assistance for acquisition or construction of buildings in the special flood hazard areas shown on the map.

The Administrator finds that delayed effective dates would be contrary to the public interest and that notice and public procedure under 5 U.S.C. 553(b) are impracticable and unnecessary.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities in accordance with the Regulatory Flexibility Act, 5 U. S. C. 601 et seq. , because the rule creates no additional burden, but lists those communities eligible for the sale of flood insurance.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, October 26, 1987, 3 CFR, 1987 Comp., p. 252.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of section 2(b)(2) of Executive Order 12778, October 25, 1991, 56 FR 55195, 3 CFR, 1991 Comp., p. 309.

The provisions of this regulation pertaining to review and adjustment of child support orders are published under the authority granted to the Secretary by section 466(a) of the Social Security Act (the Act), 42 U.S.C. 666(a). Section 466(a) requires each State to have in effect laws requiring the use of specified procedures, consistent with this section of the Act and regulations of the Secretary, to increase the effectiveness of the Child Support Enforcement program. Review and adjustment of support orders at section 466(a)(10) of the Act is one of the required procedures.

The Administrative Procedure Act requirements for notice of proposed rulemaking do not apply to rules when the agency finds that notice is impracticable, unnecessary or contrary to the public interest. We find proposed rulemaking unnecessary and contrary to the public interest, because the rule is not imposing new requirements or burdens on States, but is removing an administrative requirement and burden on agencies and families that was added to the technical corrections final regulation published in the Federal Register on May 12, 2003 (68 FR 25293). Without opportunity for public comment, that regulation implemented a substantive change to prior policy that was not warranted under any intervening amendment to the relevant statute. The change required States to adjust an order for support after a guidelines review, regardless of the amount by which the existing order is found to deviate from the State's support guidelines. The statute, as in effect before and after this change, provided that such adjustments were only required “if appropriate.” Prior to that regulation, since 1993, States could apply a reasonable quantitative standard for adjustment of an order regardless of the method of their review of the order. This regulation reinstates the prior rule with opportunity for public comment. Because the regulatory change published on May 12 did not allow for public comment, and this rule merely reinstates the prior regulation which was issued pursuant to notice and comment, advance notice is unnecessary.

Under the authority of sections 466(a)(10) and 1102 of the Act, OCSE published regulations on review and adjustment of child support orders in 1992. They were effective in October, 1993. In the preamble to that regulation, the basis for seeking an adjustment to an order was described as paraphrased below.

In the 1992 regulation, 45 CFR 303.8(d) specified the requirements States had to meet in seeking adjustments to child support orders in IV-D cases. Paragraph (d)(1) required that an inconsistency between the existent child support order amount and the amount of child support which resulted from application of the State guidelines must be an adequate basis, under State law, for petitioning for an adjustment of an order in a IV-D case, whether or not the order was established using guidelines.

Paragraph (d)(2) of the 1992 regulation provided for an exception that allowed States to establish a quantitative standard based upon either a fixed dollar amount or percentage, or both, as a basis for determining whether an inconsistency is adequate grounds for petitioning for adjustment of the order. That quantitative standard, or threshold, was to be used as a basis for determining whether the inconsistency was sufficient to justify proceeding with a petition or motion for adjustment of an award, not as a criterion for deciding whether to review. Threshold standards were not needed if States adjusted all orders regardless of the degree of inconsistency with the guidelines. However, thresholds could serve to prevent inundating the adjustment process with cases in which the variance was minimal between the current order amount and the amount that would result from an application of the guidelines.

The quantitative standard permitted by the 1992 regulation was meant to be used as a post-review decision-making tool. It was not intended to restrict the use of guidelines in setting and modifying support nor to limit the authority of the court or other authority to find, in a particular case, that an award based on guidelines was unfair or inappropriate. In making any adjustment to the amount of support, the judicial or administrative process still had to apply the State guidelines. Under regulations at 45 CFR 302.56, Guidelines for setting child support awards, the child support award calculated to be due under the guidelines was rebuttably presumed to be the correct amount of support to be paid.

OCSE issued policy on review and adjustment of orders in OCSE-AT-97-10 on July 30, 1997, in response to provisions of Pub. L. 104-193, the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, relating to review and adjustment. In that action transmittal, OCSE continued to permit States to use a reasonable quantitative standard for determining whether or not to adjust an order. Pertinent questions and answers from the action transmittal are summarized below.

Q. 4. Does the requirement to “adjust the order in accordance with the guidelines * * * if the amount * * * differs” preclude a State law providing a threshold deviation of, for example, 15% before an adjustment is deemed appropriate?

A. No. Section 466(a)(10)(A)(i)(I) of the Act, as amended by section 351 of Pub. L. 104-193, does not preclude a State law from providing a threshold deviation before an adjustment of an order is appropriate. First of all, according to section 466(a)(10)(A)(i) of the Act, the State must take “into account the best interests of the child involved.” A small reduction in support, or even an increase, because of a deviation in the guidelines' amount might not be in the child's best interests. Secondly, statute and regulations allow the State to adjust the order, or determine that there should be no adjustment, if appropriate, in accordance with the State's guidelines for setting child support awards. Given the latitude States have to apply cost-of-living adjustments, or to set thresholds if they use automated methods, it was stated that there was similar latitude for States to determine that small deviations are “inappropriate” for adjustment.

Given the complexity of the most States” review and adjustment process, as well as State child support guidelines, it may not be in the child's best interest for parents, child support agencies, and courts to wrangle over very small amounts of money. The application of child support guidelines often involves far more than a simple calculation of a portion of a parent's income. Both the review process and the adjustment process are time-consuming and involve multiple parties in most States. Despite authority in the Federal statute, very few States have automated review processes in place and about half the States have court-based systems for adjusting orders.

Q. 7. Under section 466(a)(10)(A)(i)(I) of the Act, does “if appropriate” mean that if a State reviews a case under the 3-year cycle provision using State guidelines, it can determine not to adjust the order if the inconsistency between the current order and the guideline's amount does not meet the “reasonable quantitative standard established by the State”?

A. Yes. Under section 466(a)(10)(A)(i)(I) of the Act, the language “if appropriate, adjust the order” is consistent with regulations which said that, if a State reviews a case under the 3-year cycle provision using State guidelines, it can determine not to adjust the order if the inconsistency between the current order and the guideline amount does not meet the “reasonable quantitative standard established by the State”. Under the regulations, the State could establish a reasonable quantitative standard based upon either a fixed dollar amount or percentage, or both, as a basis for determining whether an inconsistency between the existent child support award amount and the amount of support which resulted from application of the guidelines was adequate grounds for petitioning for adjustment of the order. Therefore, a reasonable quantitative standard could be used to determine not to adjust the order.

Q. 8. Is it only under section 466(a)(10)(A)(i)(III) that a State can establish a standard for determining when an adjustment is warranted?

A. No. Under both sections 466(a)(10)(A)(i)(I) (guidelines review) and (III) (automated review), as amended by section 351 of Pub. L. 104-193, it is appropriate for the State to use its threshold standard to determine if an adjustment is appropriate.

Q. 10. Under section 466(a)(10)(A)(ii) of the Act does “if appropriate” mean that a State can determine not to (re)adjust the order if the inconsistency between current and guideline support does not merit an adjustment based on the “reasonable quantitative standard established by the State”?

A. Yes. Under section 466(a)(10)(A)(ii) of the Act (opportunity to contest an adjustment), a State can determine not to (re)adjust the order if the inconsistency between current and guideline support does not merit an adjustment based on the reasonable quantitative standard established by the State.

In OCSE-AT-97-10, OCSE said it was working on a regulation to eliminate inconsistencies between title IV-D regulations and Pub. L. 104-193. That regulation was published in the Federal Register on May 12, 2003. (68 FR 25293). That regulation did not retain the regulatory policy described above. Rather, it limited use of the reasonable quantitative standard to adjustments in cases that were reviewed by automated methods. In the preamble to the May 12 rule, we said: “We are revising paragraph (c) to clarify that States may use a quantitative standard only in cases involving the use of automated methods in accordance with section 466(a)(10)(A)(i)(III) of the Act. That section alone refers to orders being “eligible for adjustment,” recognizing there might be some standard set to determine eligibility for adjustment. The other two methods of review (guidelines and cost-of-living) do not contain this language. Sections 303.8(a) and (d) through (f) remain as published in the interim final rule.”

The change to paragraph (c) in the May 12 final rule was not required by any change in the underlying statute, and it clearly was not mandated by Pub. L. 104-193, as the statute was interpreted in OCSE-AT-97-10. Nor should the change have been issued in a final rule without opportunity for comment. The interim final regulation in today's Federal Register reinstates the original rule with opportunity for public comment.

Under this interim rule a State may establish a reasonable quantitative standard, based on either a fixed dollar amount or percentage, or both, as a basis for determining whether an inconsistency between the existent child support award amount and the amount of support determined as a result of a review is adequate grounds for petitioning for adjustment of the order, regardless of the method of review. This interim final rule allows States to manage their resources and refrain from unreasonably small order adjustments that may be costly and perhaps involve changes to States' automated systems. Most States' review and adjustment process, as well as State child support guidelines, are complex and lengthy. The application of child support guidelines often involves far more than a simple calculation of a portion of a parent's income, including decisions with respect to child care, health insurance, and extraordinary medical expenses. Both the review process and the adjustment process are time-consuming and involve multiple parties in most states. Despite authority in the Federal statute for automated review and adjustment and cost-of-living increases, very few States have these automated review processes in place and about half the States have court-based, rather than administrative, systems for adjusting orders.

The rule minimizes the burden, stress and uncertainty families would face in opening up the orders to change despite little anticipated gain. In addition, the rule reduces complex agency and tribunal record-keeping that could lead to errors and lessens the burden on employers who would need to respond to constantly adjusting income withholding orders to address small differences in the amount withheld.

It is important to note that § 303.8 continues to require States to review child support orders at least every 3 years, upon request of a parent in any case, and upon request of the State if there is an assignment of support rights under title IV-A of the Act, and make adjustments, if appropriate, if the reasonable quantitative standard for an adjustment is met. Further, under paragraph (b)(5) of this section, a State must have procedures under which a parent or other person who has standing may request a review and adjustment outside the regular 3-year (or shorter) cycle, and if the requesting party demonstrates a substantial change in circumstance, the State must adjust the order in accordance with its support guidelines.

No new information collection requirements are imposed by these regulations, nor are any existing requirements changed as a result of their promulgation. Therefore, the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), regarding reporting and record keeping, do not apply.

The Secretary certifies, under 5 U.S.C. 605(b), as enacted by the Regulatory Flexibility Act (Pub. L. 96-354), that this rule will not result in a significant impact on a substantial number of small entities. The primary impact is on State governments. State governments are not considered small entities under the Act.

Executive Order 12866 requires that regulations be reviewed to ensure that they are consistent with the priorities and principles set forth in the Executive Order. The Department has determined that this rule is consistent with these priorities and principles because there is broad agreement among state IV-D agencies that removal of the burden, and reinstatement of prior policy, is necessary. Individuals, either those owing or those entitled to receive child support, will not be harmed, as only small adjustments (either up or down) in the amount of the child support obligation will be avoided. This regulation is considered a “significant regulatory action” under 3f of the Executive Order, and therefore has been reviewed by the Office of Management and Budget.

Section 202 of the Unfunded Mandates Reform Act of 1995 requires that a covered agency prepare a budgetary impact statement before promulgating a rule that includes any Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year.

If a covered agency must prepare a budgetary impact statement, section 205 further requires that it select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with the statutory requirements. In addition, section 203 requires a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

We have determined that the interim final rule will not result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of more than $100 million in any one year. Accordingly, we have not prepared a budgetary impact statement, specifically addressed the regulatory alternatives considered, or prepared a plan for informing and advising any significantly or uniquely impacted small governments.

This regulation is not a major rule as defined in 5 U.S.C. chapter 8.

Section 654 of the Treasury and General Government Appropriations Act of 1999 requires Federal agencies to determine whether a proposed policy or regulations may affect family well-being. If the agency's determination is affirmative, then the agency must prepare an impact assessment addressing seven criteria specified in the law. These regulations will not have an impact on family well-being as defined in the legislation.

Executive Order 13132 on Federalism applies to policies that have Federalism implications, defined as “regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on the States, or on the distributions of power and responsibilities among the various levels of government”. This rule does not have Federalism implications for State or local governments as defined in the Executive Order.

The Federal Procurement Data System (FPDS) is the primary database of the Federal Government for information relating to Federal procurement. GSA, in keeping with its vision of providing greater transparency into Government contracting, announced that it will pay the costs to provide three years of free access to the public to data in the FPDS and to provide for a reduced cost for a special direct web services connection to the database.

Following is a description of the methods the public will be able to use to get data from FPDS.

The public will have access to the FPDS data using several methods:

• A copy of data can be made available using FTP (file transfer protocol) from the FPDS web site.

• Prewritten queries (that can be customized to produce data for specified period and organizations) can be used that will produce reports.

• Ad hoc queries can be written by members of the public to produce reports on nearly any desired set of FPDS data.

• Direct web services connection can be established between a public computer and the FPDS computers to use FPDS as a data source.

The first three methods are free. This rule concerns the fee for the fourth.

This interim rule establishes the one-time hook-up fee that will be charged to individuals, companies, or organizations wishing direct web services access to the database. They will be required to pay a $2,500 fee to partially cover the cost of technical support, testing, and certification of direct integration to the FPDS web services. However, they will not be required to pay a fee for the data itself. Direct access to the database may be restricted to non-peak hours, depending on level of demand and FPDS's ability to service the demand without degradation of service to other users.

We expect only a few requests for the direct integration to the FPDS web services. We expect that nearly all of the public users will use the free data and report generation tools that will also be available. The public will use the same report generation tools as Federal employees to access the database. They will have access to the same data as Federal employees and they can generate the same reports as Federal employees, with minor exceptions. Certain data may be delayed and will not be available in real-time in order to guard against inappropriate release of data that could reveal pace of operations information.

GSA previously charged citizens a price for FPDS data, representing the costs incurred by GSA for providing the information.

This rule is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This interim rule is not a major rule under 5 U.S.C. 804.

We certify that the amendments will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , because we do not expect a substantial number of small entities to request direct web services access to the FPDS database. Nearly all public access to the FPDS database is expected to occur via the free report generation tools and free data provided by GSA. GSA will consider comments from small entities concerning the affected GSAR Subpart 504.6 in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite GSAR case 2004-G509, in correspondence.

The Paperwork Reduction Act does not apply because this interim rule does not contain any information collection requirements that require the approval of the Office of Management and Budget (OMB) under 44 U.S.C. 3501, et seq.

A determination has been made under the authority of the Administrator of General Services that compelling reasons exist to promulgate this interim rule without prior opportunity for public comment. This rule is necessary to establish the rate of payment for the connection fee for direct web access to the FPDS database. Access is planned to begin immediately after December 31, 2004, and there is insufficient time to obtain public comments prior to that date. Comments received in response to the publication of this interim rule will be considered in formulating the final rule.

NAFO has established and maintains conservation measures in its Regulatory Area that include one effort limitation fishery as well as fisheries with total allowable catches (TACs) and member nation quota allocations. The principal species managed are cod, flounder, redfish, American plaice, halibut, capelin, shrimp, and squid. At the 2004 NAFO Annual Meeting, the United States received fish quota allocations for three NAFO stocks and an effort allocation for one NAFO stock to be fished during 2005. The species, location, and allocation (in metric tons or effort) of these U.S. fishing opportunities, as found in Annexes I.A, I.B, and I.C of the 2005 NAFO Conservation and Enforcement Measures, are as follows:

Additionally, U.S. vessels may be authorized to fish any available portion of the 1,000 mt allocation of oceanic redfish in NAFO Subarea 2 and Divisions 1F and 3K allocated to NAFO members that are not also members of the Northeast Atlantic Fisheries Commission. Fishing opportunities may also be authorized for U.S. fishermen in the “Others” category for: Division 3LNO yellowtail flounder (76 mt); Division 3NO white hake (500 mt); Division 3LNO skates (500 mt); and Division 3O redfish (100 mt). Procedures for obtaining NMFS authorization are specified below.

Expressions of interest to fish for any or all of the U.S. fish quota allocations and “Others” category allocations in NAFO will be considered from U.S. vessels in possession of a valid High Seas Fishing Compliance (HSFC) permit, which is available from the NMFS Northeast Regional Office (see ADDRESSES ). All expressions of interest should be directed in writing to Patrick E. Moran (see ADDRESSES ). Letters of interest from U.S. vessel owners should include the name, registration, and home port of the applicant vessel as required by NAFO in advance of fishing operations. In addition, any available information on intended target species and dates of fishing operations should be included. To ensure equitable access by U.S. vessel owners, NMFS may promulgate regulations designed to choose one or more U.S. applicants from among expressions of interest.

Note that vessels issued valid HSFC permits under 50 CFR part 300 are exempt from multispecies permit, mesh size, effort-control, and possession limit restrictions, specified in 50 CFR parts 648.4, 648.80, 648.82 and 648.86, respectively, while transiting the U.S. exclusive economic zone (EEZ) with multispecies on board the vessel, or landing multispecies in U.S. ports that were caught while fishing in the NAFO Regulatory Area, provided:

(1) The vessel operator has a letter of authorization issued by the Regional Administrator on board the vessel;

(2) For the duration of the trip, the vessel fishes, except for transiting purposes, exclusively in the NAFO Regulatory Area and does not harvest fish in, or possess fish harvested in, or from, the U.S. EEZ;

(3) When transiting the U.S. EEZ, all gear is properly stowed in accordance with one of the applicable methods specified in 50 CFR part 648.23(b); and

(4) The vessel operator complies with the HSFC permit and all NAFO conservation and enforcement measures while fishing in the NAFO Regulatory Area.

Expressions of interest in harvesting the U.S. portion of the 2005 NAFO 3M shrimp effort allocation (1 vessel/100 days) will be considered from owners of U.S. vessels in possession of a valid HSFC permit. All expressions of interest should be directed in writing to Patrick E. Moran (see ADDRESSES ).

Letters of interest from U.S. vessel owners should include the name, registration and home port of the applicant vessel as required by NAFO in advance of fishing operations. In the event that multiple expressions of interest are made by U.S. vessel owners, NMFS may promulgate regulations designed to choose one U.S. applicant from among expressions of interest.

Relevant NAFO Conservation and Enforcement Measures include, but are not limited to, maintenance of a fishing logbook with NAFO-designated entries; adherence to NAFO hail system requirements; presence of an on-board observer; deployment of a functioning, autonomous vessel monitoring system; and adherence to all relevant minimum size, gear, bycatch, and other requirements. Further details regarding these requirements are available from the NMFS Northeast Regional Office, and can also be found in the current NAFO Conservation and Enforcement Measures on the Internet (see ADDRESSES ).

In the event that no adequate expressions of interest in harvesting the U.S. portion of the 2005 NAFO 3L shrimp quota allocation and/or 3M shrimp effort allocation are made on behalf of U.S. vessels, expressions of interest will be considered from U.S. fishing interests intending to make use of vessels of other NAFO Parties under chartering arrangements to fish the 2005 U.S. quota allocation for 3L shrimp and/or the effort allocation for 3M shrimp. Under NAFO rules in effect through 2005, a vessel registered to another NAFO Contracting Party may be chartered to fish the U.S. effort allocation provided that written consent for the charter is obtained from the vessel's flag state and the U.S. allocation is transferred to that flag state. NAFO Parties must be notified of such a chartering operation through a mail notification process.

A NAFO Contracting Party wishing to enter into a chartering arrangement with the United States must be in full current compliance with the requirements outlined in the NAFO Convention and Conservation and Enforcement Measures including, but not limited to, submission of the following reports to the NAFO Executive Secretary: provisional monthly catches within 30 days following the calendar month in which the catches were made; provisional daily catches of shrimp taken from Division 3L; provisional monthly fishing days in Division 3M within 30 days following the calendar month in which the catches were made; observer reports within 30 days following the completion of a fishing trip; and an annual statement of actions taken in order to comply with the NAFO Convention. Furthermore, the United States may also consider a Contracting Party's previous compliance with the NAFO incidental catch limits, as outlined in the NAFO Conservation and Enforcement Measures, before entering into a chartering arrangement.

Expressions of interest from U.S. fishing interests intending to make use of vessels from another NAFO Contracting Party under chartering arrangements should include information required by NAFO regarding the proposed chartering operation, including: the name, registration and flag of the intended vessel; a copy of the charter; the fishing opportunities granted; a letter of consent from the vessel's flag state; the date from which the vessel is authorized to commence fishing on these opportunities; and the duration of the charter (not to exceed six months). More details on NAFO requirements for chartering operations are available from NMFS (see ADDRESSES ). In addition, expressions of interest for chartering operations should be accompanied by a detailed description of anticipated benefits to the United States. Such benefits might include, but are not limited to, the use of U.S. processing facilities/personnel; the use of U.S. fishing personnel; other specific positive effects on U.S. employment; evidence that fishing by the chartered vessel actually would take place; and documentation of the physical characteristics and economics of the fishery for future use by the U.S. fishing industry.

In the event that multiple expressions of interest are made by U.S. fishing interests proposing the use of chartering operations, the information submitted regarding benefits to the United States will be used in making a selection. In the event that applications by U.S. fishing interests proposing the use of chartering operations are considered, all applicants will be made aware of the allocation decision as soon as possible. Once the allocation has been awarded for use in a chartering operation, NMFS will immediately take appropriate steps to notify NAFO and transfer the U.S. 3L shrimp quota allocation and/or the 3M shrimp effort allocation to the appropriate Contracting Party.

After reviewing all requests for allocations submitted, NMFS may decide not to grant any allocations if it is determined that no requests meet the criteria described in this notice. All individuals/companies submitting expressions of interest to NMFS will be contacted if an allocation has been awarded. Please note that if the U.S. portion of the 2005 NAFO 3L shrimp quota allocation and/or 3M shrimp effort allocation is awarded to a U.S. vessel or a specified chartering operation, it may not be transferred without the express, written consent of NMFS.

Regulations governing the summer flounder fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is apportioned on a percentage basis among the coastal states from North Carolina through Maine. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.100.

The initial total commercial quota for summer flounder for the 2004 calendar year was set equal to 16,920,000 lb (7,674,862 kg) (69 FR 2074, January 14, 2004). The percent allocated to vessels landing summer flounder in North Carolina is 27.44584 percent, resulting in a commercial quota of 4,643,836 lb (2,106,430 kg). The adjusted 2004 allocation was reduced to 4,163,464 lb (1,888,535 kg) due to research set-aside and quota overages from 2003. However, on March 9, 2004 (69 FR 10937), NMFS published notification of a commercial quota restoration of 451,595 lb (204,842 kg) to North Carolina increasing the commercial quota to 4,615,059 lb (2,093,377 kg).

Section 648.101(b) requires the Administrator, Northeast Region, NMFS (Regional Administrator) to monitor state commercial quotas and to determine when a state's commercial quota has been harvested. NMFS then publishes a notification in the Federal Register to advise the state and to notify Federal vessel and dealer permit holders that, effective upon a specific date, the state's commercial quota has been harvested and no commercial quota is available for landing summer flounder in that state. The Regional Administrator has determined, based upon dealer reports and other available information, that North Carolina has harvested its quota for 2004.

The regulations at § 648.4(b) provide that Federal permit holders agree, as a condition of the permit, not to land summer flounder in any state that the Regional Administrator has determined no longer has commercial quota available. Therefore, effective 1800 hours, December 26, 2004, through 2400 hours, December 31, 2004, further landings of summer flounder in North Carolina by vessels holding summer flounder commercial Federal fisheries permits are prohibited for the remainder of the 2004 calendar year, unless additional quota becomes available through a transfer and is announced in the Federal Register . Effective 1800 hours, December 26, 2004, through 2400 hours, December 31, 2004, federally permitted dealers are also notified that they may not purchase summer flounder from federally permitted vessels that land in North Carolina for the remainder of the calendar year, or until additional quota becomes available through a transfer.

This action is required by 50 CFR part 648 and is exempt from review under E.O. 12866.